Q1a(R2)-2003-新原料药及新制剂稳定性研究(中英文)VIP免费

StabilityTestingofNewDrugSubstancesandProducts新原料药及新制剂稳定性研究Q1a(R2)INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEICHHARMONISEDTRIPARTITEGUIDELINESTABILITYTESTINGOFNEWDRUGSUBSTANCESANDPRODUCTSQ1A(R2)CurrentStep4versiondated6February2003ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.第1页共21页StabilityTestingofNewDrugSubstancesandProducts新原料药及新制剂稳定性研究Q1a(R2)ICH指导原则新药物与新产品稳定性研究Q1A（R2）2003.2.6现行第4版Q1A(R2)DocumentHistoryFirstCodificationHistoryDateNewCodificationNovember2005Q1ApprovalbytheSteeringCommitteeunderStep2andreleaseforpublicconsultation.16September1992Q1Q1AApprovalbytheSteeringCommitteeunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.Q1wasrenamedQ1A.27October1993Q1AQ1A(R)ApprovalbytheSteeringCommitteeofthefirstrevisionunderStep2andreleaseforpublicconsultation.7October1999Q1A(R1)Q1A(R)ApprovalbytheSteeringCommitteeofthefirstrevisionunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.8November2000Q1A(R1)CurrentStep4versionQ1A(R2)ApprovalbytheSteeringCommitteeofthesecondrevisiondirectlyunderStep4withoutfurtherpublicconsultation,toincludeconsequencesoftheadoptionofQ1F(StabilityDataPackageforRegistrationApplicationsinClimaticZonesIIIandIV),andrecommendationforadoptiontothethreeICHregulatorybodies.6February2003Q1A(R2)第2页共21页StabilityTestingofNewDrugSubstancesandProducts新原料药及新制剂稳定性研究Q1a(R2)CoverNoteforRevisionofQ1A(R)StabilityTestingofNewDrugSubstancesandProducts新药物与新产品稳定性研究Q1A（R）修正说明ThepurposeofthisnoteistooutlinethechangesmadeinQ1A(R)thatresultfromadoptionofICHQ1F“StabilityDataPackageforRegistrationApplicationsinClimaticZonesIIIandIV”.Thesechangesare:本注释的目的是概述R1A（R）的变化，这些变化是因采纳了ICHQ1F，即“在气候带III和IV地区注册申请的稳定性研究要求”这一指导原则而产生的，内容包括：1.Theintermediatestorageconditionhasbeenchangedfrom30°C±2°C/60%RH±5%RHto30°C±2°C/65%RH±5%RHinthefollowingsections:2.1.7.1DrugSubstance-StorageConditions-GeneralCase2.2.7.1DrugProduct-StorageConditions-GeneralCase2.2.7.3Drugproductspackagedinsemi-permeablecontainers3Glossary-“Intermediatetesting”下列章节中，中间放置环境由30±2/60%RH±5%℃℃修正为30±2/65%RH±5%℃℃2.1.7.1原料药-放置条件-一般情况2.2.7.1制剂-放置条件-一般情况2.2.7.3半渗透容器包装的制剂3术语-“中间试验”2.30°C±2°C/65%RH±5%RHcanbeasuitablealternativelong-termstorageconditionto25°C±2°C/60%RH±5%inthefollowingsections:2.1.7.1DrugSubstance-StorageConditions-GeneralCase2.2.7.1DrugProduct-StorageConditions-GeneralCase在下列章节中，30±2/65%RH±5%℃℃可作为长期试验放置条件25±2/60%RH±5%℃℃的合适替代条件：2.1.7.1原料药——放置条件——一般情况2.2.7.1制剂——放置条件——一般情况3.30°C±2°C/35%RH±5%RHhasbeenaddedasasuitablealternativelong-termstorageconditionto25°C±2°C/40%RH±5%andthecorrespondingexamplefortheratioofwater-lossrateshasbeenincludedinthefollowingsection:2.2.7.3Drugproductspackagedinsemi-permeablecontainers在下列章节中，30±2/35%RH±5%℃℃已作为长期放置条件5±2/40%RH±5%℃℃的合适替代条件，相应的计算失水率比值的例...